FDA 483 - Torrent Pharmaceuticals Limited - June 12, 2024

This FDA Form 483 details observations from an inspection, highlighting significant deficiencies in quality control, stability testing, and manufacturing practices.

**Key Violations and Observations:**

* **Stability Testing Program Deficiencies:** No program exists to assess drug product stability, and the Quality Unit failed to ensure products sold in the US market are stable throughout their shelf life. * **Out-of-Trend (OOT) Results and Release:** 34 batches had valid OOT results for Assay by HPLC, 35 for Assay by HPLC 1, and 1 each for degradation impurities and Assay by HPLC, but were released and sold into the US market from October 2022 to May 2024, deviating from procedure CQA-070-06. The impact of these OOT results on product shelf life was not evaluated. Annual stability batches also showed valid OOT results on long-term stability, yet remained in the market. * **Historical Stability Trend Issues:** Historical stability trends revealed a potential for drug product assay to decrease, leading to a Field Alert Report (FAR) for Tablets USP on June 11, 2024, due to the risk of OOT transitioning to Out-of-Specification (OOS) before expiry. * **Unexpected Assay Increases:** Several lots showed unexpected increases in Assay by HPLC (e.g., +4% at 12 months, +